( ( An estimated 16 million colonoscopies are performed annually in the US at a cost of about $24B, however current colonoscopes with forward vision fail to detect 25-40% of precancerous polyps. Over 70% of the missed polyps are located on or behind numerous folds in the colon where they are hidden from the sight of a forward-view colonoscope. In this research proposal, we propose to complete our development of an imaging system that provides unprecedented forward as well as 360-degree reverse views in a single image. In our STTR Phase I study, we successfully developed our second prototype and re-confirmed the substantial superiority of our Dual View technique over standard colonoscopy. The technology was invented by the co- founders of the company, a gastroenterologist and an optical scientist at the University of Arizona and has been licensed by Omniscient. Device development was guided by feedback from endoscopists and industry executives. In this proposal we will further miniaturize the device, improve resolution and build an imaging system that can be integrated with any commercial endoscopy platform. Our market research indicated an overwhelming need for an `add-on' that can be used in conjunction with existing endoscopes, rather than a totally new endoscope. In collaboration with the University of Arizona, Omniscient will develop an imaging system where a capsule with a diameter of about 4 mm can be attached to the tip of any existing colonoscope to provide endoscopists with unprecedented forward and 360-degree backwards views in a single display monitor. This reusable endoscopic accessory will avoid the need and expense of replacing an endoscopy platform, allow our product to be highly cost-effective and permit the endoscopist to continue to use their preferred endoscope. We have assembled a multi-disciplinary team and formed collaborations with industry partners in lens fabrication, camera manufacturing and medical device marketing to facilitate the successful development and market launch of our product. We will continue to use end-use and market feedback to fine- tune the development of this imaging system while following regulatory standards. Omniscient has contacted the US Food and Drug Administration and will complete in-vivo colonoscopy studies in pigs, as well as reprocessability tests needed for regulatory approval. In the latter stages of this research, the company will begin organizing multi-center human studies that should lead to product launch following regulatory approval. Our extraordinary technology will transform the way colonoscopy is performed. It will greatly enhance polyp detection, prevent more cancers and reduce the national expenditure for colonoscopy.
Colonoscopy is the preferred screening procedure to prevent colon cancer, but is far from perfect as current endoscopes fail to see behind folds and around corners, leading to missed lesions and unexpected cancers. We will complete the development of an affordable, reusable, Dual-View device that can be used with any existing endoscopes to provide forward and backwards views in the same image. We will evaluate it in the pig colon and assess its reusability to meet FDA requirements for regulatory approval.